Traumatic Brain InjuryPREDICT-TCMNCT04854954
Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University Hospital, Brest at 1 site in France.
Trial summary
Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2021to 22 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults admitted in Brest hospital (ICU and wards) between 2015 and 2018 for moderate TB
Who may be able to join
- Adults
- Admitted in Brest hospital between 2015 and 2018 for moderate TBI, defined by Glasgow coma scale (GCS) score 9-13
Who cannot join
- Non consenting patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury : an Observational Study
Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary neurologic deterioration
SND was defined either by a decrease in GCS or by a deterioration in neurologic status sufficient to warrant intervention like mechanical ventilation, transfer to the ICU or neurosurgical intervention
Measured: Within 7 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start3 Feb 2021
- Primary completion22 Feb 2021
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854954
- Sponsor's protocol ID
- PREDICT-TCM (29BRC20. 0136)
- Acronym
- PREDICT-TCM
- Status last verified
- Jan 2021
- First submitted
- 19 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Aries P, Ognard J, Cadieu A, Degos V, Huet O. Secondary Neurologic Deterioration After Moderate Traumatic Brain Injury: Development of a Multivariable Prediction Model and Proposition of a Simple Triage Score. Anesth Analg. 2024 Jan 1;138(1):171-179. doi: 10.1213/ANE.0000000000006460. Epub 2023 Apr 25.
PubMed 37097898
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury : an Observational Study
- ClinicalTrials.gov ID
- NCT04854954
- Acronym / sponsor ID
- PREDICT-TCM / PREDICT-TCM (29BRC20. 0136)
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults admitted in Brest hospital (ICU and wards) between 2015 and 2018 for moderate TB
Key inclusion criteria (2 listed)
- Adults
- Admitted in Brest hospital between 2015 and 2018 for moderate TBI, defined by Glasgow coma scale (GCS) score 9-13
Key exclusion criteria (1 listed)
- Non consenting patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Secondary neurologic deterioration
Time frame: Within 7 days after hospital admission
SND was defined either by a decrease in GCS or by a deterioration in neurologic status sufficient to warrant intervention like mechanical ventilation, transfer to the ICU or neurosurgical intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Derived from this study: PubMed 37097898Aries P, Ognard J, Cadieu A, Degos V, Huet O. Secondary Neurologic Deterioration After Moderate Traumatic Brain Injury: Development of a Multivariable Prediction Model and Proposition of a Simple Triage Score. Anesth Analg. 2024 Jan 1;138(1):171-179. doi: 10.1213/ANE.0000000000006460. Epub 2023 Apr 25.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary neurologic deterioration (time frame: Within 7 days after hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.